GUDIDData
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eudamed_udi Primary ID: 20884838009466

SOLID GEL ECG ELECTRODE, 5/POUCH (UDI 20884838009466)

Manufactured by Philips Medical Systems

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SOLID GEL ECG ELECTRODE, 5/POUCH - Primary ID 20884838009466

Device Regulatory Overview

The SOLID GEL ECG ELECTRODE, 5/POUCH (Model/Catalog Number: M4612A) is a medical device manufactured by Philips Medical Systems. This product is indexed under FDA Product Code / Category Classification Z1203020202 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0745-2016 View Full Alert →

DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0010-2017 View Full Alert →

Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-0012-2017 View Full Alert →

Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
M4612A
Product Code / EMDN
Z1203020202
Device Name
Electrocardiographic Electrodes
Database Sync Date
2026-08-09 16:58:26

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of SOLID GEL ECG ELECTRODE, 5/POUCH?

The registered manufacturer of record for SOLID GEL ECG ELECTRODE, 5/POUCH is Philips Medical Systems.

What is the Primary UDI-DI identifier for SOLID GEL ECG ELECTRODE, 5/POUCH?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 20884838009466.

What classification code is assigned to this device?

This device is registered under product classification code Z1203020202.

Similar Classification Devices (Z1203020202)

Other Devices by Philips Medical Systems

Programmatic Export

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